Effect of Curcumin on Lung Inflammation

January 20, 2012 updated by: Amir Sharafkhaneh, Baylor College of Medicine

Chronic obstructive pulmonary disease (COPD) and lung cancer are leading causes of death and health care use. Diffuse airways inflammation is seen in COPD and is thought to be the reason for deterioration of lung function in COPD. Currently there is no medication available that can modify or reduce this inflammation. Furthermore, from literature review it has been shown that chronic inflammation can result in cancerous changes.

Curcumin is a food additive used for centuries. Several studies showed that curcumin suppress the different inflammatory pathways. Specially, the TNF-alpha and the NF kappa-b are down regulated by this substance. This study was designed to evaluate effect of combination of curcumin+Bioprine on sputum cytology in patients with COPD. This is double-blind randomized pilot study.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age equal or more than 45 with moderate COPD: FEV1/FVC ratio less than 70 percent; post bronchodilator FEV1 less than 50 percent
  • 20 pack year cigarette smoking
  • Stable clinical course (symptoms/ medications) for 8 weeks
  • Fixed address/Not planning to leave
  • Being able to perform spirometry
  • Able to understand and consent

Exclusion Criteria:

  • Other chronic respiratory diseases such as asthma, interstitial fibrosis, sarcoidosis
  • Heart failure NYH III & IV; symptomatic liver or renal failure
  • Dementia or other neurocognitive deficit preventing completion of symptom diary
  • Use of inhaled or systemic corticosteroids within 8 weeks of enrollment in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Curcumin+bioprine
The study involves active arm of Curcumin+Bioprine
Drug: Curcumin+Bioprine
The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sputum dysplasia
Time Frame: 3 months
We evaluated presence of moderate or worse dysplasia at baseline and each subsequent visits. The primary endpoint of this study is change in sputum cytological abnormality (moderate or worse dysplasia). The change will be comparison of 3-month follow up compared to baseline.
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events in each arm of the study.
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baylor College of Medicine

Collaborators

M.D. Anderson Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-17419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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